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A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors

Phase 2
21 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Trial of Intravenous Cereport (RMP-7) and Carboplatin in Childhood Brain Tumors


- Determine the objective response rate in patients with recurrent or refractory
childhood brain tumors treated with lobradimil and carboplatin.

- Determine the time to progression in patients treated with this regimen.

- Assess the toxicity of this regimen in this patient population.

- Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients are stratified according to histology (high-grade glioma vs low-grade glioma vs
brainstem or visual pathway glioma vs medulloblastoma/primitive neuroectodermal tumor vs
ependymoma). (Brainstem glioma stratum closed to accrual as of 12/21/2000.) (High-grade
glioma stratum closed to accrual as of 01/08/2002.)

Patients receive carboplatin IV over 15 minutes and lobradimil IV over 10 minutes on days 1
and 2. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease
progression or unacceptable toxicity. After completion of course 12, patients may receive
additional courses at the discretion of the institutional investigator.

Quality of life is assessed at baseline and then every 3 courses.

Patients are followed every 3 months for 1 year or until evidence of disease progression or
initiation of a new therapy.

PROJECTED ACCRUAL: A maximum of 146 patients will be accrued for this study within 2-4

Inclusion Criteria


- Histologically confirmed childhood brain tumor that is recurrent or refractory or for
which no standard chemotherapy exists

- High-grade glioma (anaplastic astrocytoma or glioblastoma multiforme)
(High-grade glioma stratum closed to accrual as of 01/08/2002)

- Low-grade glioma

- Medulloblastoma/primitive neuroectodermal tumor (PNET)

- Ependymoma

- Brainstem tumor or visual pathway glioma (with radiographic evidence only)
(Brainstem glioma stratum closed to accrual as of 12/21/2000)

- Evidence of recurrent or progressive disease after front-line therapy documented as
an increase in tumor size or appearance of new lesion(s) on MRI

- Patients who did not previously receive radiotherapy as front-line therapy are
eligible at time of second recurrence if the first recurrence was treated with
radiotherapy only

- Measurable disease in at least 2 dimensions by MRI

- Diffuse meningeal involvement not considered measurable if it is the only site
of disease

- Disease must not be limited to the meninges

- No metastases outside of the CNS



- 21 and under at diagnosis

Performance status:

- ECOG 0-2

Life expectancy:

- At least 8 weeks


- Absolute granulocyte count at least 1,000/mm^3

- Hemoglobin at least 8.0 g/dL (transfusion allowed)

- Platelet count at least 100,000/mm^3


- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGPT no greater than 2.5 times ULN

- No significant hepatic illness


- Creatinine within limits as defined below by age:

- Age 5 and under: less than 1.2 mg/dL

- Age 6 to 10: less than 1.5 mg/dL

- Age 11 to 15: less than 1.8 mg/dL

- Age 16 and over: less than 2.4 mg/dL


- No significant cardiac illness


- No significant pulmonary illness


- No significant systemic illness or organ dysfunction that would preclude study

- No allergic reaction to platinum-containing compounds

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- At least 72 hours since filgrastim (G-CSF)

- No concurrent biologic therapy for brain tumor


- See Disease Characteristics

- No prior carboplatin or lobradimil

- No more than 1 prior chemotherapy regimen for high-grade glioma, low-grade glioma, or

- No more than 2 prior chemotherapy regimens for medulloblastoma/PNET

- At least 4 weeks since prior nitrosoureas (2 weeks if also received stem cell/bone
marrow rescue)

- At least 2 weeks since any other prior myelosuppressive chemotherapy and recovered

- No other concurrent chemotherapy for brain tumor

Endocrine therapy:

- Concurrent corticosteroids for management of tumor-related edema allowed


- See Disease Characteristics

- At least 6 weeks since prior radiotherapy to measurable disease and recovered

- No concurrent radiotherapy for brain tumor


- No concurrent surgery except for ventriculo-peritoneal shunt placement or revision


- At least 24 hours since prior vasodilating agents, angiotensin-converting enzyme
inhibitors, calcium channel blockers, or beta-blockers

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Katherine Warren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood low-grade cerebral astrocytoma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • recurrent childhood medulloblastoma
  • untreated childhood visual pathway and hypothalamic glioma
  • recurrent childhood visual pathway and hypothalamic glioma
  • recurrent childhood ependymoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
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University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
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Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Vermont Cancer Center Burlington, Vermont  05401-3498
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
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St. Vincent Hospital and Health Care Center Indianapolis, Indiana  46260
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Bronson Methodist Hospital Kalamazoo, Michigan  49007
Geisinger Medical Center Danville, Pennsylvania  17822-0001
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Huntsman Cancer Institute Salt Lake City, Utah  84112
Marshfield Clinic Marshfield, Wisconsin  54449
Loma Linda University Medical Center Loma Linda, California  92354
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Baptist Hospital of Miami Miami, Florida  33176-2197
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New York Medical College Valhalla, New York  10595
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Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Deaconess Medical Center Spokane, Washington  99210-0248
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
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Madigan Army Medical Center Tacoma, Washington  98431-5048
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City of Hope Comprehensive Cancer Center Duarte, California  91010
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Albert Einstein Clinical Cancer Center Bronx, New York  10461
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
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Children's Hospital of Oakland Oakland, California  94609-1809
Lucile Packard Children's Hospital at Stanford Palo Alto, California  94304
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Childhood Hematology/Oncology Associates Denver, Colorado  80218
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University of Miami-Jackson Memorial Hospital Miami, Florida  33136
Medical Center of Central Georgia Macon, Georgia  31201
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University of Illinois at Chicago Chicago, Illinois  60612
Hope Children's Hospital Oak Lawn, Illinois  60453
Southern Illinois University School of Medicine Springfield, Illinois  62794-9658
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Raymond Blank Memorial Hospital for Children Des Moines, Iowa  50308
Kosair Children's Hospital Louisville, Kentucky  40202-3830
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St. Louis Children's Hospital Saint Louis, Missouri  63110
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Columbia Presbyterian Hospital New York, New York  10032
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Dakota Cancer Institute Fargo, North Dakota  58103-4940
Children's Hospital Medical Center of Akron Akron, Ohio  44308
Children's Medical Center - Dayton Dayton, Ohio  45404
St. Vincent Mercy Medical Center Toledo, Ohio  43608
Toledo Children's Hospital Toledo, Ohio  43601
Forum Health-Tod Childrens Hospital Youngstown, Ohio  44501
Children's Hospital of Oklahoma Oklahoma City, Oklahoma  73104
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Palmetto Health South Carolina Cancer Center Columbia, South Carolina  29203
Sioux Valley Hospital Sioux Falls, South Dakota  57117
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Texas Tech University Health Sciences Center School of Medicine Amarillo, Texas  79106
Children's Hospital of Austin Austin, Texas  78701
Covenant Children's Hospital Lubbock, Texas  79410
Methodist Health Care System San Antonio, Texas  78229-3902
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
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Mary Bridge Children's Health Center Tacoma, Washington  98415-0299
Cabell-Huntington Hospital, Inc Huntington, West Virginia  25701
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University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
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